| Summary: | Axicabtagene ciloleucel (Yescarta) is one of two currently approved cluster of differentiation (CD19)-directed genetically modified autologous T-cell immunotherapies. Axicabtagene ciloleucel is indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Treatment consists of leukapheresis, whereby patient's white blood cells are removed from their body and these T cells are genetically modified to express a chimeric antigen receptor (CAR). These anti-CD19 CAR T cells are then expanded and a single infusion is administered back into the patient. Each patient receives lymphodepleting chemotherapy prior to infusion of axicabtagene ciloleucel into the patient's bloodstream. Axicabtagene ciloleucel is recommended as an autologous single infusion of approximately 68 mL suspension with a target dose of 2 × 106 anti-CD19 CAR-positive viable T cells per kg of body weight (range: 1 to 2.0 × 106 cells per kg). This report is based on a critical appraisal of the economic evidence submitted by the manufacturer, which consisted of an economic evaluation and a budget impact analysis (BIA). CADTH conducted reanalyses to consider alternative assumptions and inputs where relevant and possible
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